Wednesday, April 06, 2005

Despite Loopholes, No Improvements in FDA Tobacco Legislation

An analysis conducted by Barron's Online has confirmed that the FDA tobacco legislation introduced in Congress this session is nearly identical to the bill that was defeated in Conference Committee last session. Economic analyst Bonnie Herzog wrote in a March 30 article that despite a broader array of initial support for the bill, chances for passage in 2005 remain low.

The Rest of the Story

These findings suggest that despite being aware of numerous flaws in the FDA tobacco legislation, the major organizations that supported this legislation last session did not insist upon any changes to strengthen it.

While there are problems in the bill's overall regulatory approach that I think render it inappropriate from a public health policy perspective (see previous posts: post 1post 2post 3), there are still a number of improvements that could have been made. These were outlined in a policy analysis that I prepared last year. They include the following:

Section 906(d)(1) (General Provisions Respecting the Control of Tobacco Products): Delete the phrase "No such regulation may require that the sale or distribution of a tobacco product be limited to the written or oral authorization of a practitioner licensed by law to prescribe medical products." This is a scientific and regulatory policy matter and should not be politicized.

Section 906(d)(3)(A): Delete ("No restrictions under paragraph (1) may--`(i) prohibit the sale of any tobacco product in face-to-face transactions by a specific category of retail outlets; or `(ii) establish a minimum age of sale of tobacco products to any person older than 18 years of age.") This is a scientific and regulatory policy matter and should not be politicized.

Section 907(a)(4)(b)(v): Delete ("provision requiring that the sale and distribution of the tobacco product be restricted but only to the extent that the sale and distribution of a tobacco product may be restricted under a regulation under section 906(d))." This is a scientific and regulatory policy matter and should not be politicized.

Section 907(b)(3)(A): Delete ("Because of the importance of a decision of the Secretary to issue a regulation establishing a tobacco product standard--`(A) banning all cigarettes, all smokeless tobacco products, all little cigars, all cigars other than little cigars, all pipe tobacco, or all roll your own tobacco products; or `(B) requiring the reduction of nicotine yields of a tobacco product to zero, Congress expressly reserves to itself such power.") This is a scientific and regulatory policy matter and should not be politicized.

Section 915: Delete and replace with the following: "Section 801 of Title V of the United States Code does not apply to the regulations referred to in the Family Smoking Prevention and Tobacco Control Act." This would eliminate the short-circuited process by which Congress can override FDA rules under the current bill.

I think that for each of the loopholes above, public health advocates deserve an explanation as to: (1) why each of these compromises are present in the legislation; (2) who requested or demanded that these compromises be present in the legislation; and (3) why the Campaign for Tobacco-Free Kids did not insist upon their removal from the bill. Knowing the source of these loopholes as well as the reasons for their inclusion in the bill and the precise reasons why the Campaign for Tobacco-Free Kids did not insist upon their removal is essential before tobacco control practitioners can make an informed decision about their support or opposition to this legislation.

Perhaps the most concerning aspect of this story is Herzog's conclusion that the chances for passage of this bill in its present form are slim. This means that in order to secure its passage, amendments that further weaken the bill will almost certainly be required. Do public health advocates really want the Campaign for Tobacco-Free Kids to be in a position of making decisions for all of us about further compromises in the legislation?

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About Me

Dr. Siegel is a Professor in the Department of Community Health Sciences, Boston University School of Public Health. He has 32 years of experience in the field of tobacco control. He previously spent two years working at the Office on Smoking and Health at CDC, where he conducted research on secondhand smoke and cigarette advertising. He has published nearly 70 papers related to tobacco. He testified in the landmark Engle lawsuit against the tobacco companies, which resulted in an unprecedented $145 billion verdict against the industry. He teaches social and behavioral sciences, mass communication and public health, and public health advocacy in the Masters of Public Health program.